Device
4004-418 URT CUSPID 3T/8A DHK 018 PK
Manufacturer
3M UNITEK CORPORATION
Model: 4004--418 Catalog: 4004--418 DI: 00652221228154 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-07 Current Version: 2026-05-15
Description
4004-418 URT CUSPID 3T/8A DHK 018 PK
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 485fba85-4f76-4b3d-a85e-f89406803f40
Distribution Status: In Commercial Distribution
DUNS Number: 008256356
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00652221228154
Type: Primary
Issuing Agency: GS1
GMDN
Code:
Name:
FDA Product Codes
DYH
ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
EJF
BRACKET, METAL, ORTHODONTIC